European Pharmacopoeia Training Resources

In line with its commitment to providing clear and timely insight into its work and activities, the EDQM makes the resources of its training sessions publicly available for the benefit of those stakeholders who could not attend in person.

The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. This webinar covers how the implementation of ICH Q3D impacts on Ph. Eur. texts and on the assessment of CEP applications. The recording includes the Q&A session after the presentations.

Biologicals in the twenty-PhEur-st Century (Webinar recorded on 19 March 2015)Language: English - Duration: 1 hour, 20 minutes

This webinar will give an overview of the main Ph. Eur. texts dealing with biologicals, with a specific focus on biotech products. It will also discuss the flexibility provided by the Ph. Eur. including examples of QbD approaches for biologicals and the role of the Ph. Eur. within the biosimilar context.

Raw Materials for the Production of Cell-based and Gene Therapy Medicinal Products (Webinar recorded on 09 November 2017)Language: English - Duration: 1 hour, 30 minutes

The aim of this webinar is to explain the context of the elaboration of the new European Pharmacopoeia (Ph. Eur.) general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products and its scope. The first part of the webinar will give an introduction to the Ph. Eur. and its place within the EU regulatory network. The second part will be dedicated to the general chapter 5.2.12 and will provide information on the context of its elaboration followed by an overview of the chapter and the class of raw materials of biological origin covered.

This webinar will give a general overview of the principles for finished product monographs with chemically defined active substances within the Ph. Eur., the content of these monographs and an update on the work programme. The monograph on Sitagliptin tablets (2927) will also be covered.

This webinar will be in two parts. The first part will give a brief introduction to the Ph. Eur., some background into the history of this general chapter and highlight the changes that were introduced in Ph. Eur. (Supplement 8.3). The second part will focus on the revision of the chapter with an overview on hydrolytic resistance and delamination risk.

Reverse osmosis in the Ph. Eur. monograph for Water for Injections (WFI) (Webinar recorded on 22 April 2015)Language: English - Duration: 1 hour, 10 minutes

This webinar will start with a general introduction to the Ph. Eur. and the background of this history of water monographs. It will also give an overview of actions taken by the Ph. Eur. towards the revision of the WFI monograph, an update on the status of the revision of the WFI monograph and the consequences of the revision on other Ph. Eur. texts covering quality of water.